BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LORENZ LARYNGEAL PROSTHESIS 7.5MM

    MDR report key: 7448185 · Received April 20, 2018

    Report

    Report Number
    0001032347-2018-00211
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    FWN
    PMA / PMN Number
    PK896667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO A PREVIOUS DESIGN. THE PRODUCT HAS NOT BEEN DISTRIBUTED SINCE (B)(6) 2016. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED SINCE THE PROCEDURE REPORTED IN 0001032347-2018-00031 "THE CHILD HAS BEEN BROUGHT BACK TO THE OPERATING ROOM NUMEROUS TIMES FOR DILATION OF AIRWAY. WE ARE GOING TO BRING HIM BACK SOON TO HAVE ANOTHER RECONSTRUCTIVE SURGERY." ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290644 COTTON-LORENZ LARYNGEAL PROSTHESIS 7.5MM STENT FWN BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R